Quality System Specialist

🔥 1 hour ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $70k - $80k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

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Medical Informatics Corp.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2010

🏥 Healthcare

☁️ SaaS

🏢 Enterprise

💰 $5M Debt Financing - Medical Informatics on 2025-01

Healthcare • SaaS • Enterprise

Medical Informatics Corp. is a healthcare software company that delivers Sickbay, a software-driven platform that unifies and virtualizes patient monitoring across health systems. Sickbay centralizes physiological data from medical devices and integrates with EHRs to enable Virtual Ops, continuous telemetry, analytics, automated workflows, and collaboration across clinical, research, and operational teams. The platform is positioned to improve remote monitoring, escalate early warning indicators (e. g. , decompensation scores), support vICU/pulse center workflows, and make monitoring data visible, analyzable, and actionable across enterprise healthcare organizations.

📋 Description

• Lead and support the planning, execution, and documentation of internal audits in alignment with audit standards and organizational risk priorities. • Develop and prepare audit materials, and oversee the collection and evaluation of audit evidence to ensure accuracy and completeness. • Maintain comprehensive and well-organized audit documentation and records to support findings and regulatory requirements. • Monitor, track, and report audit findings, ensuring timely remediation and closure of corrective actions. • Drive cross-functional coordination to address audit findings, ensuring alignment with regulatory, compliance, and internal control requirements. • Provide guidance to stakeholders on risk mitigation strategies and control improvements. • Manage and track CAPAs, including initiation, root cause investigation, corrective action planning, and effectiveness verification. • Ensure CAPAs are documented, progressed, and closed within required timelines. • Support investigation and documentation of nonconformances and ensure proper escalation where required. • Maintain traceability between nonconformances, CAPAs, and related documentation. • Compile and maintain the Software Nonconformance (NC) log, ensuring accurate tracking, status updates, and reporting. • Ensure completeness and compliance of Design History Files (DHF) and related documentation within the eQMS. • Support cross-functional teams in ensuring design documentation aligns with internal procedures and regulatory requirements (e.g., IEC 62304, ISO 13485). • Support the Director of Compliance in coordinating both internal and external audits and regulatory inspections (e.g., ISO, FDA).

🎯 Requirements

• Bachelor's degree in Computer Science, Engineering, or a related technical field, or equivalent experience. • 4+ years of work experience in the medical device industry (SaMD preferred). • 2+ years experience with regulatory standards including ISO 13485:2016, ISO 14971:2019, and 21 CFR 820. • 2+ years of experience in Software Product Development and Technical Writing. • Demonstrated experience executing and participating in internal/external audits and CAPA Management. • Strong verbal and written communication skills, with proven capability to develop, review, edit, and proofread technical and regulatory compliance documentation. • Strong organizational, time management, and project management skills, with a high attention to detail and the ability to manage multiple concurrent priorities independently and collaboratively across cross-functional teams. • Proficient in learning and utilizing new technologies and tools, including GitHub, Confluence, Greenlight Guru (eQMS), Smartsheet, and Google Workspace.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off